| Conditions: |
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Schizophrenia - Schizoaffective Disorder - Major Depression - Bipolar Disorder - Coronary Artery Disease |
| Purpose: |
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The purpose of this study is to determine whether the administration of omega-3
polyunsaturated fatty acids, particularly eicosapentaenoic acid (EPA), can be useful both to
reduce coronary artery disease (CAD) risk and illness severity in clinically-stable patients
with schizophrenia (or schizoaffective disorder), major depression or bipolar disorder
(depressed phase) being treated with lipid lowering drugs (e.g., statins).
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| Study Summary: |
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We propose to study the effects of EPA (2 g of EPA in 4 x 500 mg capsules daily) compared to
placebo supplementation in clinically-stable schizophrenic patients being treated with
statins (n=30 each) for 4 months using a randomized, double-blind design. The National
Cholesterol Education Program Adult Treatment Panel III guidelines will be used to select
those patients with CAD risk to participate. Clinical assessments and comprehensive
assessment of the risk for CAD, including plasma total, high-density lipoprotein (HDL)-
(HDL2- and HDL3-), low-density lipoprotein (LDL)- (LDL-Real-, Lp(a)-, and IDL-), and VLDL-
(VLDL1,2- and VLDL3-) cholesterol, plasma triglycerides, as well as plasma homocysteine and
high sensitivity C-reactive protein, will be conducted at baseline, 1 month, 2 months and 4
months after supplementation. It is anticipated that patients who receive EPA
supplementation will have significantly greater reduction in plasma triglycerides and
LDL4-cholesterol, and increases in HDL2-cholesterol measures, as well as improvements in
psychopathology severity than those patients receiving placebo. If indeed EPA is effective
in decreasing the risk of CAD, any psychiatric benefits from EPA supplementation will be a
further boon to the patients and the treatment team. A tremendous advantage to the clinical
use of EPA includes low cost, no significant side effects, and ease of use.
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| Criteria: |
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Inclusion Criteria:
- Patients meeting Diagnostic and Statistical Manual of Mental Disorders - Fourth
Edition (DSM-IV) criteria for schizophrenia (or schizoaffective disorder), major
depression, or bipolar (depressed phase) disorder who are treated with antipsychotic,
antidepressant or antimanic drugs and a lipid-lowering drug (statin) for 2 months or
longer will be screened to participate in the proposed project.
- Based upon the CAD risk determinants (see below) and the National Cholesterol
Education Program (NCEP) recommendation of goals for LDL-lowering therapy, the
investigators will only enroll schizophrenic patients with baseline (before statin
treatment) LDL-cholesterol exceeding:
- 70 mg/dL having CAD and CAD risk equivalents, e.g., peripheral arterial disease,
abdominal aortic aneurysm, symptomatic carotid artery disease, and diabetes, as
well as multiple risk factors that confer a 10-year risk for CAD > 20%
- 130 mg/dL having 2 or more risk factors; and
- 160 mg/dL having less than 2 risk factors to participate in the EPA trial.
In addition, these CAD-risk patients have not reached the NCEP goal level within the past
year following statin treatment.
- Risk factors for CAD. The NCEP Expert Panel (NIH Publication No. 01-3670, May 2001)
on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult
Treatment Panel III or ATPIII) recognizes the following CAD risk factors:
- being male, 45 years or older, or being female 55 years or older;
- family history of premature CAD;
- current cigarette smoking;
- hypertension with 140/90 mmHg or greater; and
- low HDL-cholesterol (less than 40 mg/dL).
Exclusion Criteria:
- Patients with history of bleeding disorders, current drug or alcohol abuse (within
one month), neurological disorders (including head injury with loss of consciousness
for greater than 10 minutes), antisocial personality disorder, borderline personality
disorder, or mental retardation as indicated in medical records
- Patients who are pregnant (as determined by urine pregnancy test)
- Patients who have already achieved their NCEP goal in terms of their lipid profile
(as indicated in laboratory tests) will be excluded.
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| NCT ID: |
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NCT00167310 |
| Primary Contact: |
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Principal Investigator
Jeffrey K Yao, Ph.D., FACB
University of Pittsburgh and VA Pittsburgh Healthcare System
Jack Haflett, B.S.
Phone: (412)954-5779
Email: jack.haflett@va.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15206
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |